Clinical trial · Interventional
Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer.
Phase II Multicenter Randomized Study to Compare Neoadjuvant FDC With Melatonin or Metformin Versus FDC Alone in The Therapy of Locally Advanced Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the addition melatonin and metformin to conventional chemotherapy FDC (Fluoruracil, Doxorubicin, cyclophosphamide) in the treatment of locally advanced breast cancer. Third of patients will receive FDCх6 cycles, other third will receive combination of melatonin and FDCх6 cycles and other patients will receive combination of metformin and FDCх6 cycles.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Fluoruracil | Drug | — | UNRESOLVED |
| melatonin | Drug | — | UNRESOLVED |
| metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- FDC x 6 cycles with metformin
- description
- 32 patients will receive 5 - Fluoruracil 500 mg/m\^2, doxorubicin 50 mg/m\^2, cyclophosphamide 500 mg/m\^2 once every 21 days with metformin 850 mg BID
- interventionNames
- Drug: metformin
- Drug: Fluoruracil
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- FDC x 6 cycles with melatonin
- description
- 32 patients will receive 5 - Fluoruracil 500 mg/m\^2, doxorubicin 50 mg/m\^2, cyclophosphamide 500 mg/m\^2 once every 21 days with melatonin 3 mg before sleep daily
- interventionNames
- Drug: Fluoruracil
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: melatonin
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18. Obtained Inform Consent Morphologically confirmed breast cancer stage IIB, IIIA,IIIB,IIIC. ( triple negative, luminal B) Eastern Collaborative Oncology Group Performance Status Scale 0 - 2. Expected survival \>6 month Adequate liver and bone marrow function Exclusion Criteria: * Systemic treatment for breast cancer IV stage disease Evidence of liver and bone marrow clinically meaningful disfunction Severe uncontrolled concomitant conditions and diseases Pregnancy or lactation Second malignancy Diabetes mellitus requiring drug therapy Any condition preventing study participation by investigator opinion
References
Publications (0)
Data not yet available